- LOGIN
- MemberShip
- 2026-05-19 23:04:58
- Policy
- GSK’s dutasteride+tamsulosin combo finally enters Korea
- by Lee, Tak-Sun May 20, 2021 05:57am
- GSK will be introducing its fixed-dose ‘Avodart(dutasteride)’ and tamsulosin combination for the treatment of prostatic hyperplasia for the first time in Korea. The domestic approval has come 10 years after the approval by EMA and FDA. Considering that the combined prescription of the abovementioned two drugs is common in the prostatic hyperplasia treatment market, whether the introduction of this combination drug will change the market structure is the focus of interest. The Ministry of Food and Drug Safety (MFDS) granted GSK’s ‘Duodart capsule’ marketing approval on the 18th. Duodart capsule is a fixed-dose combination of dutasteride and tamsulosin used for the treatment of moderate-to-severe symptoms of Benign Prostatic Hyperplasia (BPH). The recommended dose of Duodart is one capsule taken orally approximately 30 minutes after the same meal each day. Duodart is a combination of two drugs - dutasteride, a dual 5α-reductase inhibitor (5-ARI), and tamsulosin hydrochloride, an antagonist of α1a-adrenoreceptors - with complementary mechanisms of action to improve symptoms in patients with benign prostatic hyperplasia (BPH). In a 4-year clinical trial of 4,844 men with BPH (the CombAT study), the group that was co-administered with dutasteride-tamsulosin showed superior symptom improvement over monotherapy of either drug at year 2. Based on the results, EMA had approved the drug in April 2010, and the FDA in June 2010. In other words, the Duodart cap, is being approved in Korea 10 years after being approved by leading authorities abroad. Also, the MFDS assigned a re-examination period for Duodart capsule until May 17th, 2027. During the re-examination period, generics made with the same ingredient cannot enter the market. Companies in Korea have also been working hard to develop a combination treatment for prostatic hyperplasia, but no products have been commercialized so far. Chong Kun Dang is conducting a Phase III trial on its tamsulosin+tadalafil combination, and Dongkook Pharmaceuticals’s dutasteride+tadalafil combination has also entered a Phase III trial. Also, Ildong Pharmaceutical and Jeil Pharmaceutical has completed the clinical trial for their tamsulosin+solifenacin combination. More recently, Dongkoo Bio&Pharma and KyungDong Pharm have entered a Phase III trial to develop their tamsulosin+mirabegron combination. However, perhaps due to GSK’s early success with the dutasteride and tamsulosin combination in 2010, the same combination has not been studied in Korea. Hanmi Pharmaceutical had received export approval for the same combination in 2017 but withdrew the approval in August last year. Pharmaceutical companies have been keen to develop a combination drug since a high proportion of patients use two drugs in combination for the treatment of prostatic hyperplasia. In particular, prescription of the tamsulosin and dutasteride combination is very common in the field, drawing more attention to the approval of GSK’s combination drug. The market for prostatic hyperplasia treatment is estimated to be around 400 billion won. Currently, Astellas has a strong influence over the market as it owns the original drugs such as tamsulosin, etc. Whether GSK will rise as the new dark horse with its combination drug is receiving much interest. Meanwhile, GSK’s dutasteride is also indicated for the treatment of hair loss among men in addition to symptomatic benign prostatic hyperplasia.
- Policy
- Generic for Madopar by Myungin was first licensed
- by Lee, Tak-Sun May 20, 2021 05:56am
- Madopar (Benserazide HCl/Levodopa) by Roche is the treatment for Parkinson's syndrome, and the generic was approved in Korea. Myungin, which is drawing attention in related markets for Perkin and Trilevo, is expected to expand its sales with the joining of generic for Madopar . The MFDS approved Myungdopar by Myungin on the 14th. Myungdopar is a drug used in Parkinson's syndrome that is generic for Roche's Madopar. It is the first generic to be introduced in Korea. After receiving approval for the first biological equivalence test plan in May 2019, Myungin began developing generic for Madopar . A single oral administration of Myungdopar to healthy adults was conducted to measure Levodopa in the blood of 57 people, demonstrating that the mean 90% confidence interval with Madopar was biological equivalent from log 0.8 to log 1.25. Madopar is a combination of dopamine precursors Levodopa and Benserazide. Levodopa reaches the brain region and increases dopamine levels. It is also a drug with Benserazide added to help sufficient amounts of Levodopa leap into the brain. This treats symptoms associated with Parkinson's disease dance and tonic. Madopar recorded ₩9 billion in outpatient Rx (UBIST) last year, ranking second after Lundbeck's Azilect (₩9.9 billion) among Parkinson's disease treatments. Myungin stands out in the treatment of Parkinson's disease as a generic company. Myungin has several treatments for Parkinson's disease, including Trilevo (generic for Stalevo) and Perkin (generic for Sinemet). Trilevo was ranked No. 1 in the generic market with ₩6 billion last year, while Perkin was ranked No. 3 with ₩3.6 billion. Rasalin, the No. 1 product in the market, was also released last year. Myungdopar, first generic for Madopar, is expected to serve as a new opportunity for Parkinson's disease treatment market.
- Company
- Zopista for insomnia to be prescribed at general hospitals
- by Eo, Yun-Ho May 20, 2021 05:56am
- The insomnia treatment ‘Zopista,’ which can be prescribed long-term, is now cleared for prescription at general hospitals. According to industry officials, Huons’ Zopista(eszopiclone) passed the Drug Committees (DCs) of the Big-5s - Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital – and many other major medical institutions in the nation. Zopista was first introduced in Korea along with its reimbursement approval in November 2019. However, as the drug has been prescribed in the U.S. since 2004, its generics have also soon entered the Korean market, expanding the competition. With no domestic patent or Post Market Surveillance (PMS) period set for the drug, there was no way for the company to deter or block the entrance of its generics. However, with Huons successfully landing its product in general hospitals, whether Zolpidem can maintain its share in the market as the leading product remains to be seen. Contrary to other existing insomnia treatments like ‘Zolpidem,’ Zopista can be used long-term. In case of Zolpidem, its long-term use is not recommended, and the treatment period is regulated to not exceed 4 weeks. However, according to a survey by the Health Insurance Review and Assessment Service, insomnia is a common condition that 1 out of 3 adults in Korea experience, with its market rapidly growing as the number of insomnia patients rose 48.3% from 2013 to 2017. Considering that a relatively small number of patients currently receive treatment for insomnia due to low recognition of the disease, the potential for growth in the market is high.
- Company
- Piqray has been released in Korea
- by May 20, 2021 05:56am
- The first new drug targeting the PIK3 gene in breast cancer has been released in Korea. The MFDS approved Piqray (Alpelisib/50·150·200 mg' by Novartis on the 13th. Piqray is HR- (+)/HER2 (-) and may be combined with the endocrine treatment Faslodex (Fulvestrant) in postmenopausal women and men with progressive or metastatic breast cancer. PIK3CA positive diagnostic tests are evaluated using in vitro diagnostic medical devices licensed by the MFDS. It is the first domestic PIK3 inhibitor. It also obtained permission from the U.S. and Europe in May 2019 and July 2020, respectively. PIK3CA genetic variation is known to be a common pattern in about 40% of patients with HR+/HER2- breast cancer. Sporadic genetic mutations can mutate independently of family history. If PIK3CA mutations are latent, they can lead to cancer proliferation as well as resistance to endocrine therapy and poor prognosis. In a three-phase SOLAR-1 study conducted by Novartis, Piqray and Fulvestrant combined therapy approximately doubled the primary evaluation variable, Progressive Survival Period (PFS). The median survival period for the combined therapy group was 11.0 months and 5.7 months for the sole therapy group. Overall response rate (ORR), an indicator of the proportion of patients who experience at least a 30% reduction in overall tumor size (in patients with measurable disease), was more than doubled when Piqray was added to Fulvestrant in patients with a PIK3CA mutation, (ORR= 35.7% vs 16.2% for fulvestrant alone, p=0.0002). There was a clinically relevant improvement in OS of eight months for patients with a PIK3CA mutation taking Piqray plus Fulvestrant compared to Fulvestrant alone (median OS 39.3 months vs. 31.4 months). This difference did not reach the prespecified threshold of statistical significance set for the secondary objective of OS in patients with PIK3CA-mutated breast cancer. In terms of safety, most of them were mildly reactive, which can be managed by dose control, and the rate that led to discontinuation of medication was similar to that of the sole therapy group. However, during the administration period, patients may experience severe skin irritation due to drugs, which requires management. The MFDS recommended that Piqray be stopped if the skin is more than 30% toxic to the body surface. As the first PIK3CA-targeted treatment that can meet unmet demand has crossed the licensing threshold, attention is expected to be focused on whether to be reimbursed for combined therapy.
- Company
- IQVIA acquires Korean healthcare marketing firm MMK
- by Eo, Yun-Ho May 18, 2021 05:52am
- The healthcare big data company IQVIA has acquired MMK Communications. Industry sources said that IQVIA Korea had completed the merger and acquisition of MMK communications, expanding its business area to digital consulting services. MMK Communications is a company that provides digital detailing services including webinars and call center medication counseling services with nurses. It has been providing customized services in the COVID-19 pandemic during which the need for non-face-to-face communication had been rising. Through the M&A, IQVIA plans to transform into a comprehensive healthcare service provider that offers a wide range of services from Contract Research Organization (CRO) to healthcare data analytics. In 2019, the company had acquired CoreZetta, a firm that analyzes big data provided by the Health Insurance Review and Assessment Service (HIRA). After a merger between IMS Health and Quintiles, the company adopted the new name of IQVIA in 2017. Powered by IQVIA CORE, IQVIA provides customized solutions for its clients leveraging the world’s largest curated healthcare information source, advanced analytics, leading technologies, and extensive industry knowledge across diseases, geographies, and scientific methods.
- Policy
- Generic exclusivity of Alicoxib has been extended by one mon
- by Lee, Tak-Sun May 18, 2021 05:52am
- Korea Arlico PharmArlico Pharm's "Alicoxib," which acquired generic exclusivity, has been extended for one month. The MFDS allowed the application for extension in consideration of the listing period. According to the MFDS on the 17th, Alicoxib will be guaranteed exclusive rights until January 30 next year. It was extended by about a month from December 25. The entry period for the same ingredient was postponed by one month. This is because when generic exclusivity is acquired, products of the same active ingredient are not allowed to enter within 9 months. The MFDS grants a nine-month effective period, but if sales are delayed within the effective period due to registration, it is extending the period at the request of pharmaceutical companies. Alicoxib has been effective since March 26, but it was not until May 1. However, the generic exclusivity item has a registration period of two months after the application month, which is shorter than 3 months. Arlico Pharm also produces three other ingredients in addition to Alicoxib. They also acquired a generic exclusivity. In addition, six other pharmaceutical products also received generic exclusivity. They are also expected to extend the generic exclusivity period. Alicoxib (Etoricoxib) is a COX-2 inhibitor that, unlike non-selective NSAID (COX-1), selectively inhibits COX-2 induced by inflammatory reactions to relieve pain, and does not inhibit COX-1, which is associated with GIl complications. The original is MSD's Arcoxia, and recorded ₩1.7 billion (based on UBIST) in sales of outpatient Rx last year.
- Policy
- No. of clinical trials rise despite COVID-19
- by Lee, Tak-Sun May 18, 2021 05:51am
- Despite the COVID-19 outbreak last year, the number of clinical trials conducted in Korea had increased, which raised Korea’s global clinical trial rank by two steps. In particular, this was the first time the proportion of early clinical trials (Phase I, II) had exceeded the Phase III trials. Such positive results were possible with the Ministry of Food and Drug Safety (MFDS) and clinical research institutions’ quick response to the COVID-19 variable. A joint analysis by MFDS and Korea National Enterprise for Clinical Trials (KoNECT) of clinical trials aproved in 2020 showed that despite the COVID-19 crisis, the total number of trials approved last year was 799, an 11.9% point increase from the 714 in 2019. The number of approve trials had increased for 3 consecutive years to reach 799 trials last year. Among the trials, company-sponsored trials by pharmaceutical companies drove the growth, accounting for 611 (76.5%) trials, a 13.6% point increase from the 538 conducted in 2019. Looking at the 611 company-sponsored trials by each phase, the increase was focused around early clinical trials (Phase I and II). The number of Phase I and II trials among the 611 trials last year was 400, an increase from 309 in 2018 and 322 in 2019. In the past, over half of the multinational clinical trials conducted in Korea used to be Phase III trials, however, for the first time last year, the number of early clinical trials (Phase I and II) exceeded the proportion of Phase III trials. The proportion of Phase III trials among multinational clinical trials (355) rose from 55.7% in 2018 to 55.2% in 2019, then fell under 50% to mark 45.1% last year. On the other hand, among multinational clinical trials (355), the proportion of Phase I and II trials were 43.9% in 2018 and 43.8% in 2019, which then surged in 2020 to 53.5%. By efficacy, early clinical trials on anticancer drugs and infectious diseases (antibiotics etc.) had increased greatly. This is in line with the global trend, where the development of anticancer drugs and COVID-19 treatments/vaccines are being actively progressed. Phase I and II clinical trials for anticancer drugs had increased greatly from 81 in 2019 to 160 last year. The number of Phase I and II clinical trials for infectious diseases approved last year was 42. According to the clinical trial registration website developed by the National Institute of Health (NIH), the number of clinical trials increased globally last year, and Korea’s global clinical trial ranking rose two steps from the 8th in 2019 to 6th, the highest-ever rank to be recorded by Korea. The analysis is that the increase of domestic clinical trials and multinational clinical trials in Korea are a result of Korea’s rapid response to the change in clinical trial environment caused by COVID-19, and the global recognition of Korea's clinical trial competency. In particular, the increase of early clinical trials for anticancer treatment is expected to provide new opportunities to patients suffering from late-stage cancer, etc. who have no other available treatment options. “Through the operation of the ‘National infectious disease clinical trial center and the National clinical trial participant platform, we plan to establish a COVID-19 clinical trial success model and actively foster Korea's clinical trial competency." The MFDS also plans to actively support the rapid development of COVID-19 treatments and vaccines by actively resolving difficulties in clinical trial sites and operating the Institutional Review Board (IRB) while further strengthening the protection of rights and interests of clinical trial participants and reinforcing safety management of clinical trials.
- Policy
- RSA isn't enough to evaluate the benefit of first in class
- by Lee, Jeong-Hwan May 18, 2021 05:51am
- It was pointed out that in order to enhance patient accessibility of first-in-class, which costs tens of millions to billions of won per dose, and maintain national health insurance financial soundness, the first-in-class customized reimbursement model should be found. They argue that a system should be created that combines risk-sharing drugs (RSA), economic evaluation exemption, and separate fund (FUND) methods to review benefits for expensive anticancer drugs or rare genetic diseases that do not have alternative drugs. Kang Sun-woo, a member of the Democratic Party of Korea, held a parliamentary debate to strengthen access to the first-in-class of rare genetic diseases on the 13th. Kang Hye-young, a professor at Yonsei University of Pharmacy, announced the successful overseas cases of first-in-clas and the implications of the new system. Currently, the market for treatments for rare incurable diseases has proven to be effective, but the rapid development of first-in-class drugs, which cost tens of millions to billions of won, is affecting the finances of each country's health insurance. The limited health insurance budget has increased the burden that should guarantee access to drugs for a small number of patients suffering from rare diseases. Professor Kang Hye-young pointed out that the problem is that Korea has not applied or added ICER thresholds in relation to the first-in-class at the stage of evaluating benefit of drugs and drug pricing. First-in-class, which has excellent drug effectiveness and safety, requires a customized benefit model to flexibly evaluate drugs that satisfy clinical and technical innovation and social needs. Professor Kang said that RSA is also limited to anti-cancer drugs and rare disease treatments, undermining the benefit equity of various incurable disease treatments. It was suggested that the system should be created to increase patient accessibility rather than financial risk sharing based on the introduction of a suitable type of RSA for first-in-class. It is pointed out that Korea has not used the fund yet in expanding its benefit using the fund. Professor Kang said that when considering the benefit through funds, it is necessary to determine the subjects of funding, the scope of medicines eligible for support, and the scope of benefits. "Our first-in-class customized the benefit policy should recognize drug innovation and ensure patient access to unmet medical needs," Professor Kang said. "We need to prepare the system not only for quick approval of new drugs but also for smooth patient benefits."
- Company
- 11 companies join the use patent for Entresto
- by Kim, Jin-Gu May 18, 2021 05:51am
- EntrestoWhile Hanmi filed an invalidation trial with Entresto's use patent and composition patent, 11 companies, including Daewoong and Chong Kun Dang, filed for the same judgment. According to the pharmaceutical industry on the 13th, 10 companies including Chong Kun Dang, Yooyoung, Hanlim, Hana, Ahn-gook, Boryung, Yuyu, Genuonesciences, Kolmar, and Samjin filed an invitation trial for Novartis' heart failure drug Entresto patent on the 12th. Daewoong filed a request for the same judgment on the 30th of last month. As a result, a total of 12 companies are challenging Entresto's use patent and composition patent. Analysts say that the fact that Korean companies filed for the validation trial on the same day is related to generic exclusivity. It is intended to meet 'request of first trial', one of the requirements for obtaining generic exclusivity. Under the current regulations, if a particular company claims the same judgment within 14 days of the first trial, it is considered to have achieved the request of first trial requirement. Hanmi filed an invitation trial with generic exclusivity on the 29th of last month. This patent is known to be the most difficult to overcome among the four patents registered as generic exclusivity. Patents registered as generic exclusivity include ▲ use patent and composition patent, which expires in July 2027, ▲ composition patent, which expires in September 2027, ▲composition patent, which expires in November 2028, ▲ and composition patent, which expires in January 2029 etc. Entresto is a heart failure treatment with Valsartan, an ARB-based hypertension treatment, and Sacubitril, another NEP inhibitor. With each patent expired, Novartis conducted a clinical trial by combining the two ingredients and was approved as a treatment for heart failure. 20 companies, including Elyson, filed a passive trial to confirm the scope of their rights on a crystalline patent that expires in September 2027. This includes 12 companies that challenged use patent and composition patent, including Hanmi. If 12 additional companies, including Hanmi, overcome the patent, they can receive generic exclusivity on the assumption that they meet the requirements for applying for the initial item permit and enjoy generic exclusivity for nine months regardless of Elyson's success. The remaining three patents need to be overcome, but they are relatively easy to overcome and are expected to be less burdensome. Since its launch in Korea in October 2017, Entresto's prescription sales have been increasing rapidly. According to UBIST, a pharmaceutical market research firm, Entresto's prescription sales were ₩6.3 billion in 2018, the first year of its release. Last year's sales more than tripled to ₩20.3 billion in two years. Prescription sales in the first quarter of this year are ₩5.8 billion, the highest quarterly prescription amount ever.
- Policy
- Will Moderna’s COVID-19 vaccine be introduced in H1?
- by Lee, Tak-Sun May 17, 2021 05:53am
- The process for the rollout of Moderna COVID-19 vaccine in the first half of this year is gaining momentum. As the possibility obtaining marketing authorization for the imported vaccines on Friday(21st) is high, its rollout in the first half of the year is promising due to the Korea-US Summit event. In addition, the overall inspection of the distribution channels that were conducted prior to the introduction of the vaccine, including the simulation vaccine delivery training and safety inspection of GC Pharma’s logistics center in Ochang, have added strength to the possibility of Moderna’s vaccine being introduced in the first half of this year On April 12th, GC Pharma had submitted an application for the approval of Moderna’s COVID-19 vaccine. On May 13th, the Central Pharmaceutical Affairs Council (CPAC) concluded that it was reasonable to grant approval of Moderna’s vaccine for use in adults 18 years or older as a two-dose schedule. CPAC is a legal advisory board of the Ministry of Food and Drug Safety (MFDS), and the ministry is known to generally follow CPAC’s recommendations. However, in the case of COVID-19 treatments and vaccines, the MFDS receives three separate independent evaluations before granting final approval. The last expert meeting, by the ‘Final inspection Committee,' is scheduled to be held on the 21st next month. Considering that the Final Inspection Committee followed CPAC’s decision for AstraZeneca, Pfizer, and Janssen COVID-19 vaccines as well as Celltrion’s COVID-19 treatment, unless a major issue comes up, the Moderna vaccine is also likely to be granted approval. The MFDS will hold a meeting with the Final Inspection Committee to finalize the labeling details and decide whether to approve the marketing authorization of the vaccine. As the Korea-U.S Summit is scheduled on the same day, industry officials predict that the government will use the summit as an opportunity to approve the Moderna vaccine and announce its rollout schedule in Korea. Also, there have been media reports that 50,000 doses of the vaccine will arrive in Korea in the last week of May. If the vaccine is imported this month, the government’s announcement of releasing the vaccine in Korea in the 2nd half of this year will come true. In the case of the Moderna vaccine, as the company prioritized its U.S. supply, the rollout schedules in other countries were expected to be delayed by one quarter. This was why there had been strong expectations that the vaccine will be introduced in the third quarter rather than the second quarter. However, the mock delivery training for Moderna vaccines and the joint safety inspection conducted at GC Pharma’s logistics center in Ochang have supported the possibility that the introduction of the Moderna vaccine may be more imminent in Korea. In the case of these imported Moderna vaccines, the drug substance of the Moderna vaccine was first produced at the Lonza plant in Switzerland, then filled and finished by a Spanish pharmaceutical company. After its arrival in Korea, GC Pharma will take over its distribution as the license holder. Apart from the imported vaccines, the CMO deal for producing the Moderna vaccine in Korea is expected to be announced during the Korea-U.S. Summit period. The popular prospect is that Samsung Biologics will be the CMO that fills and finishes the solution in Korea. On such expectations, Samsung Biologics had publicly stated that “nothing has been finalized.” However, considering that the company drew a firm line on the rumors of a CMO deal for the Pfizer vaccine stating that “it is not true,” the rather unclear position of Samsung Biologics has added fuel to the rumor. Also, as John Rim, the CEO of Samsung Biologics will be at the South Korea-U.S. Summit, this also had added strength on the possibility of the company being the CMO for Moderna. However, even after a CMO deal, it would take some time for the CMO to actually produce the vaccines, as pharmaceuticals manufactured in Korea are required to receive a separate approval from the MFDS. The vaccines that passed the CPAC review this month were imported vaccines, therefore a separate approval is required for domestically manufactured products. AstraZeneca had also submitted two applications for its vaccine; one for the manufacture and marketing authorization of its products manufactured by its CMO SK Bioscience, and the other for the import authorization of products manufactured outside of Korea, including those from Italy.
